510(k) K030269
K030269 is an FDA 510(k) premarket notification submitted by Genicon, LC for the device "GENICON CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on March 20, 2003. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Genicon, LC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2003
- Date Received
- January 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type